drugset / Trial / NCT02064842
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of TMC647055 in Combination With Ritonavir (Part 1) and the Co-administration of TMC435, TMC647055 and Ritonavir (Part 2) in Healthy Japanese Participants
RandomizedCrossoverQuadruple-blindTreatment
Summary
The purpose of the study is to investigate the safety, tolerability, and pharmacokinetics of TMC647055 in combination with ritonavir (Part 1); potential pharmacokinetic drug-drug interactions between TMC435 and the combination of TMC647055 with ritonavir; and to evaluate the short-term safety and tolerability when TMC435, TMC647055 and Ritonavir are co-administered (Part 2) in healthy Japanese participants.
Timeline
- Start
- 2014-02
- Primary completion
- 2014-04
- Completion
- 2014-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Simeprevir | Small molecule | 75 mg | Oral |
| Subject | Simeprevir | Small molecule | 100 mg | Oral |
| Subject | Simeprevir | Small molecule | 150 mg | Oral |
| Subject | TMC647055 | Small molecule | 150 mg | Oral |
| Subject | TMC647055 | Small molecule | 450 mg | Oral |
| Subject | TMC647055 | Small molecule | 600 mg | Oral |
| Background | Ritonavir | Other / unclassified | 30 mg | Oral |
Indications
No indication recorded.